[go: up one dir, main page]
More Web Proxy on the site http://driver.im/
IDEAS home Printed from https://ideas.repec.org/a/wly/empleg/v8y2011i4p613-649.html
   My bibliography  Save this article

When Do Generics Challenge Drug Patents?

Author

Listed:
  • C. Scott Hemphill
  • Bhaven N. Sampat
Abstract
The Hatch‐Waxman Act regulates competition between brand‐name and generic drugs in the United States. We examine a feature of the Act that has attracted great controversy but little systematic attention. “Paragraph IV” challenges are a mechanism for generic drug makers to challenge the patents of brand‐name drug makers as a means to secure early market entry. We first present descriptive results that chart the rise of brand‐name patent portfolios and Paragraph IV challenges. Over time, patenting has increased, measured by the number of patents per drug and the length of the nominal patent term. Meanwhile, the fraction of drugs subjected to patent challenges has increased. Drugs are also challenged sooner, relative to brand‐name approval. Our econometric analyses of challenges over the past decade show that brand‐name sales have a positive effect on the likelihood of generic challenge. The likelihood of challenge also varies with the nature of the patent portfolio. A drug with weaker patents faces a significantly higher likelihood of challenge, conditional on sales and other drug characteristics. That is not because the drug's patent protection is weaker overall; additional patents, even weak ones, generally strengthen a brand‐name firm's ability to exclude. Rather, a weak patent, particularly if it expires later than the basic patents, disproportionately attracts a challenge to the pertinent drug. Overall, our results suggest these challenges serve a useful purpose by promoting scrutiny of weaker and late‐expiring patents.

Suggested Citation

  • C. Scott Hemphill & Bhaven N. Sampat, 2011. "When Do Generics Challenge Drug Patents?," Journal of Empirical Legal Studies, John Wiley & Sons, vol. 8(4), pages 613-649, December.
    • Handle: RePEc:wly:empleg:v:8:y:2011:i:4:p:613-649
    DOI: 10.1111/j.1740-1461.2011.01235.x
    as

    Download full text from publisher

    File URL: https://doi.org/10.1111/j.1740-1461.2011.01235.x
    Download Restriction: no
    File URL: https://libkey.io/10.1111/j.1740-1461.2011.01235.x?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    References listed on IDEAS

    as
    1. Hegde, Deepak & Sampat, Bhaven, 2009. "Examiner citations, applicant citations, and the private value of patents," Economics Letters, Elsevier, vol. 105(3), pages 287-289, December.
    2. Adam B. Jaffe & Josh Lerner, 2006. "Innovation and its Discontents," NBER Chapters, in: Innovation Policy and the Economy, Volume 6, pages 27-66, National Bureau of Economic Research, Inc.
    3. Bhaven N. Sampat, 2010. "When Do Applicants Search for Prior Art?," Journal of Law and Economics, University of Chicago Press, vol. 53(2), pages 399-416, May.
    4. G. M.P. Swann, 2009. "The Economics of Innovation," Books, Edward Elgar Publishing, number 13211.
    5. Fiona M. Scott Morton, 1999. "Entry Decisions in the Generic Pharmaceutical Industry," RAND Journal of Economics, The RAND Corporation, vol. 30(3), pages 421-440, Autumn.
    6. Henry G. Grabowski & Margaret Kyle, 2007. "Generic competition and market exclusivity periods in pharmaceuticals," Managerial and Decision Economics, John Wiley & Sons, Ltd., vol. 28(4-5), pages 491-502.
    7. Jeremy Bulow, 2004. "The Gaming of Pharmaceutical Patents," NBER Chapters, in: Innovation Policy and the Economy, Volume 4, pages 145-187, National Bureau of Economic Research, Inc.
    8. repec:bla:jindec:v:46:y:1998:i:4:p:405-32 is not listed on IDEAS
    9. Frank R. Lichtenberg & Suchin Virabhak, 2007. "Pharmaceutical-embodied technical progress, longevity, and quality of life: drugs as 'Equipment for Your Health'," Managerial and Decision Economics, John Wiley & Sons, Ltd., vol. 28(4-5), pages 371-392.
    10. Wesley M. Cohen & Richard R. Nelson & John P. Walsh, 2000. "Protecting Their Intellectual Assets: Appropriability Conditions and Why U.S. Manufacturing Firms Patent (or Not)," NBER Working Papers 7552, National Bureau of Economic Research, Inc.
    11. Fiona M. Scott Morton, 1999. "Entry Decisions in the Generic Pharmaceutical Industry," Yale School of Management Working Papers ysm119, Yale School of Management.
    12. Frank Lichtenberg, 2009. "The effect of new cancer drug approvals on the life expectancy of American cancer patients, 1978-2004," Economics of Innovation and New Technology, Taylor & Francis Journals, vol. 18(5), pages 407-428.
    13. Filson, Darren & Oweis, Ahmed, 2010. "The impacts of the rise of Paragraph IV challenges on startup alliance formation and firm value in the pharmaceutical industry," Journal of Health Economics, Elsevier, vol. 29(4), pages 575-584, July.
    14. Jean O. Lanjouw & Ariel Pakes & Jonathan Putnam, 1998. "How to Count Patents and Value Intellectual Property: The Uses of Patent Renewal and Application Data," Journal of Industrial Economics, Wiley Blackwell, vol. 46(4), pages 405-432, December.
    15. James Bessen & Michael J. Meurer, 2008. "Introduction to Patent Failure: How Judges, Bureaucrats, and Lawyers Put Innovators at Risk," Introductory Chapters, in: Patent Failure: How Judges, Bureaucrats, and Lawyers Put Innovators at Risk, Princeton University Press.
    16. David Reiffen & Michael R. Ward, 2005. "Generic Drug Industry Dynamics," The Review of Economics and Statistics, MIT Press, vol. 87(1), pages 37-49, February.
    17. Richard C. Levin & Alvin K. Klevorick & Richard R. Nelson & Sidney G. Winter, 1987. "Appropriating the Returns from Industrial Research and Development," Brookings Papers on Economic Activity, Economic Studies Program, The Brookings Institution, vol. 18(3, Specia), pages 783-832.
    18. Jean O. Lanjouw & Mark Schankerman, 2004. "Patent Quality and Research Productivity: Measuring Innovation with Multiple Indicators," Economic Journal, Royal Economic Society, vol. 114(495), pages 441-465, April.
    19. DiMasi, Joseph A. & Hansen, Ronald W. & Grabowski, Henry G., 2003. "The price of innovation: new estimates of drug development costs," Journal of Health Economics, Elsevier, vol. 22(2), pages 151-185, March.
    Full references (including those not matched with items on IDEAS)

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    Cited by:

    1. Branstetter, Lee & Chatterjee, Chirantan & Higgins, Matthew J., 2022. "Generic competition and the incentives for early-stage pharmaceutical innovation," Research Policy, Elsevier, vol. 51(10).
    2. C. Scott Hemphill & Bhaven N. Sampat, 2012. "Weak Patents Are a Weak Deterrent: Patent Portfolios, the Orange Book Listing Standard, and Generic Entry in Pharmaceuticals," NBER Chapters, in: Standards, Patents and Innovations, National Bureau of Economic Research, Inc.
    3. Sampat, Bhaven N. & Shadlen, Kenneth C., 2017. "Secondary pharmaceutical patenting: A global perspective," Research Policy, Elsevier, vol. 46(3), pages 693-707.
    4. Javad Moradpour & Aidan Hollis, 2021. "The economic theory of cost‐effectiveness thresholds in health: Domestic and international implications," Health Economics, John Wiley & Sons, Ltd., vol. 30(5), pages 1139-1151, May.
    5. Shamim S. Mondal & Viswanath Pingali, 2017. "Competition and Intellectual Property Policies in the Indian Pharmaceutical Sector," Vikalpa: The Journal for Decision Makers, , vol. 42(2), pages 61-79, June.
    6. Amy Kapczynski & Chan Park & Bhaven Sampat, 2012. "Polymorphs and Prodrugs and Salts (Oh My!): An Empirical Analysis of “Secondary” Pharmaceutical Patents," PLOS ONE, Public Library of Science, vol. 7(12), pages 1-9, December.
    7. Hemphill, C. Scott & Sampat, Bhaven N., 2012. "Evergreening, patent challenges, and effective market life in pharmaceuticals," Journal of Health Economics, Elsevier, vol. 31(2), pages 327-339.
    8. Mondal, Shamim S. & Pingali, Viswanath, 2015. "Competition Law and the Pharmaceutical Sector in India," IIMA Working Papers WP2015-11-02, Indian Institute of Management Ahmedabad, Research and Publication Department.
    9. Beall, Reed F. & Hardcastle, Lorian & Clement, Fiona & Hollis, Aidan, 2019. "How will recent trade agreements that extend market protections for brand-name prescription pharmaceuticals impact expenditures and generic access in Canada?," Health Policy, Elsevier, vol. 123(12), pages 1251-1258.
    10. Durvasula, Maya & Hemphill, C. Scott & Ouellette, Lisa Larrimore & Sampat, Bhaven & Williams, Heidi L., 2023. "The NBER Orange Book Dataset: A user’s guide," Research Policy, Elsevier, vol. 52(7).
    11. Wagner, Stefan & Sternitzke, Christian & Walter, Sascha, 2022. "Mapping Markush," Research Policy, Elsevier, vol. 51(10).
    12. Matthew J. Higgins & Mathias J. Kronlund & Ji Min Park & Joshua Pollet, 2020. "The Role of Assets In Place: Loss of Market Exclusivity and Investment," NBER Working Papers 27588, National Bureau of Economic Research, Inc.
    13. Bhaven N. Sampat, 2015. "Intellectual property rights and pharmaceuticals: The case of antibiotics," WIPO Economic Research Working Papers 26, World Intellectual Property Organization - Economics and Statistics Division.

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. C. Scott Hemphill & Bhaven N. Sampat, 2012. "Weak Patents Are a Weak Deterrent: Patent Portfolios, the Orange Book Listing Standard, and Generic Entry in Pharmaceuticals," NBER Chapters, in: Standards, Patents and Innovations, National Bureau of Economic Research, Inc.
    2. Antoine Dechezleprêtre & Yann Ménière & Myra Mohnen, 2017. "International patent families: from application strategies to statistical indicators," Scientometrics, Springer;Akadémiai Kiadó, vol. 111(2), pages 793-828, May.
    3. Gaétan de Rassenfosse & Adam B. Jaffe, 2018. "Are patent fees effective at weeding out low‐quality patents?," Journal of Economics & Management Strategy, Wiley Blackwell, vol. 27(1), pages 134-148, March.
    4. Magazzini Laura & Fabio Pammolli & Massimo Riccaboni, 2013. "R&D, Within and Between Patent Competition in the Pharmaceutical Industry," Working Papers 3/2013, IMT School for Advanced Studies Lucca, revised Jul 2013.
    5. Lee Branstetter & Chirantan Chatterjee & Matthew J. Higgins, 2016. "Regulation and welfare: evidence from paragraph IV generic entry in the pharmaceutical industry," RAND Journal of Economics, RAND Corporation, vol. 47(4), pages 857-890, November.
    6. Iain M. Cockburn & Megan J. MacGarvie, 2011. "Entry and Patenting in the Software Industry," Management Science, INFORMS, vol. 57(5), pages 915-933, May.
    7. Bernhard Ganglmair & Imke Reimers, 2019. "Visibility of Technology and Cumulative Innovation: Evidence from Trade Secrets Laws," CRC TR 224 Discussion Paper Series crctr224_2019_119v1, University of Bonn and University of Mannheim, Germany.
    8. Eric Budish & Benjamin Roin & Heidi Williams, 2013. "Do fixed patent terms distort innovation? Evidence from cancer clinical trials," Discussion Papers 13-001, Stanford Institute for Economic Policy Research.
    9. Fischer, Timo & Henkel, Joachim, 2012. "Patent trolls on markets for technology – An empirical analysis of NPEs’ patent acquisitions," Research Policy, Elsevier, vol. 41(9), pages 1519-1533.
    10. Patricia M. Danzon & Eric L. Keuffel, 2014. "Regulation of the Pharmaceutical-Biotechnology Industry," NBER Chapters, in: Economic Regulation and Its Reform: What Have We Learned?, pages 407-484, National Bureau of Economic Research, Inc.
    11. Dosi, Giovanni & Palagi, Elisa & Roventini, Andrea & Russo, Emanuele, 2023. "Do patents really foster innovation in the pharmaceutical sector? Results from an evolutionary, agent-based model," Journal of Economic Behavior & Organization, Elsevier, vol. 212(C), pages 564-589.
    12. Mohd Shadab Danish & Pritam Ranjan & Ruchi Sharma, 2021. "Identification of “Valuable” Technologies via Patent Statistics in India: An Analysis Based on Renewal Information," BASE University Working Papers 13/2021, BASE University, Bengaluru, India.
    13. Barirani, Ahmad & Beaudry, Catherine & Agard, Bruno, 2017. "Can universities profit from general purpose inventions? The case of Canadian nanotechnology patents," Technological Forecasting and Social Change, Elsevier, vol. 120(C), pages 271-283.
    14. Verniers, Isabel & Stremersch, Stefan & Croux, Christophe, 2011. "The global entry of new pharmaceuticals: A joint investigation of launch window and price," International Journal of Research in Marketing, Elsevier, vol. 28(4), pages 295-308.
    15. Andrew Eckert & Corinne Langinier, 2014. "A Survey Of The Economics Of Patent Systems And Procedures," Journal of Economic Surveys, Wiley Blackwell, vol. 28(5), pages 996-1015, December.
    16. Bastian Rake, 2017. "Determinants of pharmaceutical innovation: the role of technological opportunities revisited," Journal of Evolutionary Economics, Springer, vol. 27(4), pages 691-727, September.
    17. Mark A. Lemley & Carl Shapiro, 2005. "Probabilistic Patents," Journal of Economic Perspectives, American Economic Association, vol. 19(2), pages 75-98, Spring.
    18. Bronwyn Hall & Christian Helmers & Mark Rogers & Vania Sena, 2014. "The Choice between Formal and Informal Intellectual Property: A Review," Journal of Economic Literature, American Economic Association, vol. 52(2), pages 375-423, June.
    19. Ernst R. Berndt & Joseph P. Newhouse, 2010. "Pricing and Reimbursement in U.S. Pharmaceutical Markets," NBER Working Papers 16297, National Bureau of Economic Research, Inc.
    20. Adam B. Jaffe & Gaétan de Rassenfosse, 2017. "Patent citation data in social science research: Overview and best practices," Journal of the Association for Information Science & Technology, Association for Information Science & Technology, vol. 68(6), pages 1360-1374, June.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:wly:empleg:v:8:y:2011:i:4:p:613-649. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Wiley Content Delivery (email available below). General contact details of provider: https://doi.org/10.1111/(ISSN)1740-1461 .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.